31 Jan, 2024 FDA/CDRH's Take on the Growing Importance of Transparency in AI/ML-Enabled Medical Devices By Austin Kim Beyond traditional regulatory concerns, the U.S. Food and Drug Administration (FDA) is currently navigating the challenges of usability,...
08 Dec, 2023 Biden Threatens to Cancel Pharma Patents By Paul Hunter The U.S. government is threatening to go after companies who obtained patents on drugs developed with the help of government grants. The...
05 Dec, 2023 New FDA Tip Sheet By Jenny Wang This is a great update regarding new FDA regulations concerning the supply of critical foods including infant formula and medical foods.
28 Nov, 2023 GPT-4 Outperformed Simulated Human Readers in Diagnosing Complex Clinical Cases By Paul Hunter OpenAI's GPT-4 correctly diagnosed 52.7% of complex challenge cases, compared to 36% of medical journal readers, and outperformed 99.98%...
23 Oct, 2023 AI and 10 Seconds of Voice can Screen for Diabetes By Paul Hunter Diabetes is a chronic disease that affects millions of people worldwide. It is characterized by high blood sugar levels, which can lead...
18 Aug, 2023 Health Equity and Predictabilty Updates to ACO REACH Model 2024 By Kinal Patel CMS recently announced targeted updates to the ACO REACH Model for PY 2024 on August 15. CMS is attempting to increase predictability for...
17 Aug, 2023 How do health care providers prioritize AI investments today? By Foley & Lardner With a virtual tsunami of information and both mature and startup companies targeting AI and health care, I found this Bain and Co....
16 Aug, 2023 FDA Issues New Guidance on Informed Consent By David Rosen FDA has stated the guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying...
08 Aug, 2023 FDA Issues Guidance on Cosmetic Registration and Listing By David Rosen Cosmetic companies are required to submit facility registration and product listing information on cosmetic products that they...
08 Aug, 2023 FDA Updates to Forms 356h and 1571 By David Rosen FDA has recently revised Form 356h: Application to Market a New or Abbreviated New Drug or Biologic for Human Use and Form 1571:...
08 Aug, 2023 FDA Public Workshop on Clinical Trial Diversity By David Rosen FDA is holding a two-day virtual public workshop to enhance clinical study diversity. This workshop is being held on November 29 and 30,...
08 Feb, 2023 FTC Launches New Digital Health App Tool By Aaron Maguregui In a follow up to the FTC's Mobile Health Best Practices Guide published in December 2022, the FTC has now launched a Mobile Health App...